Application of Radiomics in the Diagnosis and Treatment Prediction of Pituitary Adenoma

Pituitary Adenoma Clinical Trial

— RIPA  

Official title:

Radiomics-based Diagnosis, Treatment and Outcome Prediction for Pituitary Adenoma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06234553
• Other study ID #: SK-748
• Secondary ID: RIPA-001
• Status: Active, not recruiting
• Start date: January 1, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: Beijing Tiantan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The images of patients with Pituitary adenoma were collected and analyzed based on the methods of radiomics.

Description:

Inclusion of pituitary adenoma patients diagnosed clinically or pathologically

1. Clinical data and pre-treatment imaging data of included patients (DICOM format)

2. Determine the subtype diagnosis of pituitary adenoma based on the patient's clinical and pathological data

3. Collect relevant data of patients before and after treatment

4. Using radiomics methods, extract radiomic features of patients and construct a radiomic model for predicting the diagnosis and treatment response of pituitary adenomas

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Gender unlimited, 18-80 years old;

2. Clinical diagnosis of Pituitary Adenoma and receive surgical treatment;

3. Received brain imaging;

4. informed consent signed

Exclusion Criteria:

1. Pregnant / lactating women

2. Contraindications of imaging examination

3. Lack of effective clinical data

4. MRI data before treatment cannot be obtained

5. Postoperative pathology not revealed pituitary adenoma

Related Conditions & MeSH terms

• Adenoma
• Pituitary Adenoma
• Pituitary Diseases
• Pituitary Neoplasms

Intervention

Procedure:
• surgery of pituitary adenomas
evaluate pathological type and treatment effect after treatment

Locations

Country	Name	City	State
China	Beijing tiantan hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence rate of pituitary adenoma	The pituitary adenoma recurred 1 year after treatment. The recurrence was assessed by 3 aspects: (1)contrast enhanced MRI showed suspicious tumor growth, such as bone destruction; (2)signs and symptoms that had disappeared after treatment reappeared, such as pressing on nearby nerve tissue and some characteristic appearance; (3)endocrine indexes rose again after reaching the remission standard, iculding Prolactin(PRL)>30 µg/L in Lactotroph adenoma; growth hormone (GH)>2.5ng/ml in Somatotroph adenoma, serum cortisol>800nmol/L at 8am in Corticotroph adenoma, while other types do not consider endocrine indicators.	1 year after treatment
Secondary	Pathological type of pituitary adenomas	The pathological examination was used to evaluated the type of pituitary adenoma. The pathological type was assessed by 2017 WHO standard, divided into Somatotroph adenoma, Lactotroph adenoma, Thyrotroph adenoma, Corticotroph adenoma, Gonadotroph adenoma, Null-cell adenoma and Plurihormonal and double adenomas.	1 week after treatment